A lot of people are now using peptide treatment because of well-known ones like Semaglutide (Ozempic/Wegovy) and Tirzepatide (Mounjaro/Zepabound). But bodybuilders, people who want to live longer, health podcasters, and biohackers are shocked that the FDA recently banned 17 other famous peptides.
What is a peptide it is a group of amino acids that your body needs to do important jobs. When injected or eaten, they can help you live longer by helping you lose weight, gain strength, keep your brain healthy, boost your libido, control your hormones, and more.
But not all peptides have been studied as much. This is one of the main reasons why the FDA just released new rules that make it harder to buy some prescription peptide treatments. Some people still sell the now-banned peptides without a legal prescription on the black market, but this is risky and not a good idea.
The FDA said it was okay for peptides that have been studied a lot and come in a set form. But peptides that hadn't been studied in humans very much were on the cutting room floor because of worries about impurities and dangerous side effects that come with compounded medicines.
Compounding pharmacies are different from regular pharmacies because they can make prescription drugs into custom topical treatments, injectables, flavored liquids, and more at exact amounts.
Compound peptides, on the other hand, might not work the same way in different methods. Because of this, the FDA is cracking down on compounding pharmacies that mix peptides that the agency thinks are unsafe or need more study.
Even though the ban starts right away, compounding shops can still use up the peptides they already have in stock.
Want to know if your favorite peptide treatment is on the list? Because the FDA banned them, the following peptides were changed. Plus, other ways to get treatment if your plan changed.
FDA Limits Have an Effect on Peptides
CJC-1295
At first glance, CJC-1295 looks like a peptide that can help you live longer in many ways. It has been shown in animal studies to improve sleep, build muscle, lose weight, improve immune and brain function, and slow down the aging process of the skin .
What made it part of the FDA ban ?
The FDA says that there is a chance that CJC-1295 will cause your heart rate to go up and cause heart problems. The government also says that compounded CJC-1295 could have peptide impurities and immune responses that are bad.
Expert Swap:
Sermorelin, like CJC-1295, helps keep your body in good shape by raising your growth hormone levels .
AOD-9604
Bodybuilders love AOD-9604 because it is said to speed up the metabolism, burn fat that won't go away, and boost muscle growth by increasing human growth hormone and decreasing insulin resistance .
The pituitary gland releases human growth hormone (HGH) to help teens grow taller, build muscle, and make bones stronger. HGH levels drop with age (4), which is why AOD-9604 is popular with people who want to build muscle.
What made it part of the FDA ban ?
It was said that AOD-9604 "had a risk for immunogenicity (the ability to cause a bad immune response), peptide-related impurities, and limited safety-related information."
Expert swap:
Tesamorelin is a man-made protein that releases growth hormone (GHRH). Tesamorelin is different from other GHRH analogs and even the normal form of the hormone found in the brain because it has the whole GHRH amino acid sequence and a trans-3 hexenoic group that keeps it from being broken down by enzymes. This makes it more stable and increases its half-life.
Ipamorelin
A growth hormone-releasing peptide (GHRP) called ipamorelin is often used to help muscles grow and improve metabolism and healing after a workout .
What made it part of the FDA ban ?
In the FDA release, the agency talks about a study in which giving ipamorelin through an IV led to major side effects, including death.
Expert swap:
One of the Growth Hormone drugs on the market that works quickly is hexarelin. When injected under the skin, it works by sending a heartbeat to the pituitary gland, which makes it work. This process makes the body release natural Growth Hormone. It makes muscles stronger and helps both new and old muscle fibers grow.
Ibutamoren
Ibutamoren, which is also known as MK-677, is a selective growth hormone secretagogue receptor (GHSR) agonist. This means that it makes your body make more of the growth hormone that helps build muscle and bones .
What made it part of the FDA ban ?
The FDA says that there were major safety concerns because of "the potential for congestive heart failure in some patients" that were seen in a clinical study that was stopped.
Expert swap:
None right now
BPC-157
Biohackers love BPC-157, also known as the "magic peptide," because it may help the brain work better, help with joint pain, and heal gut inflammation . Animal tests show that this peptide may also help with angiogenesis, which is the process by which your body creates more blood vessels.
What made it part of the FDA ban ?
The FDA says that the BPC-157 ban is because of "risk for immunogenicity, peptide-related impurities, and limited safety-related information."
You can still get BPC-157 as a pill to take by mouth. Since BPC-157 is one of the few peptides that can live in the acidic environment of your stomach , taking it by mouth is probably the best way to treat it.
Swaps by experts:
When injected, pentosan polysulfate has been shown to help with osteoarthritis and other types of joint pain (10). If you mostly take BPC-157 for joint health, this peptide might work as an option.
Body Pentadeca Complex is a partial chain of body protection compound (BPC) made up of 15 amino acids that was found in and taken out of human gastric juice. In experiments, it has been shown to speed up the healing of many types of wounds, such as tendon-to-bone healing and better healing of broken ligaments. It also looks like BPC 157 keeps organs safe and stops stomach sores. It has also been shown that this peptide can ease pain in hurt places. Someone who is in pain because of sprained, torn, or damaged muscles might feel better after taking this peptide. Not only that, but it can also help burns heal faster and get more blood to hurt areas.
Larazotide is a peptide that may make your gut lining stronger and less permeable. If you take BPC-157 to help your gut stay healthy, talk to your doctor about using this peptide instead.
DIHEXA
DIHEXA is a peptide that can cross the blood-brain barrier and is often used by people who are worried about their risk of getting degenerative diseases like Parkinson's, Alzheimer's, and dementia (16). Users say that DIHEXA makes them smarter, helps them solve problems, lowers their sadness, and remember things better.
What made it part of the FDA ban ?
Studies on animals show that DIHEXA may have these benefits for the brain (17), but the FDA says it "has not identified any human exposure data." This means that it is still not clear if DIHEXA is safe and effective for people.
Swaps by experts:
A brain healing peptide called cerebrolysin has shown promise in protecting against neurodegenerative diseases like Alzheimer's (18). Fibroblast Growth Factor may help people remember things .
Selank
Researchers are looking into selank, a peptide that helps with nervousness and brain function, to see if it can balance neurotransmitters such as serotonin, dopamine, and norepinephrine. These hormones help keep your mood and hunger in check.
What made it part of the FDA ban ?
The agency said in a press statement that Selank has a high risk of immune reactions and impurities during the compounding process.
Expert swap:
None right now
Semax
Adrenocorticotropic hormone (ACTH) controls the production of cortisol and androgens. Semax comes from this hormone. Studies show that Semax may improve memory, focus, and learning by changing the way neurotransmitters work in the brain . In animal tests, this peptide has also been shown to protect neurons by lowering oxidative stress and making the brain healthier overall .
What made it part of the FDA ban ?
When Semax is being made, there is a high chance of immune response and impurities.
Expert Swap:
A peptide called PE 22-28 is often used to treat sadness, improve memory, and stop strokes (34). If you take Semax, talk to your doctor about this peptide.
DSIP
You may have learned about DSIP in a biohacking subreddit if you can't fall asleep. DSIP is thought to raise the production of GABA (20), a chemical that lowers brain activity, helps people relax, and makes them sleep deeper for longer. Adding more GABA may help people who have trouble sleeping, according to research (21).
What made it part of the FDA ban ?
The FDA says that there is still not enough research on DSIP in people. You can, however, buy GABA tablets at a health food store near you.
Expert swap:
None right now
Epitalon
It is a man-made form of the natural peptide Epithalamin, which is made by the pineal gland. The pineal gland may be controlled by epitalon, which can increase the release of serotonin and melatonin, hormones that help you sleep.
Epitalon may also be able to lengthen your telomeres, which are the caps at the ends of your chromosomes that get shorter as you age . Cellular aging can be measured by the length of telomeres, and keeping telomeres longer is thought to slow down cellular aging.
What made it part of the FDA ban ?
Because of the risk of peptide impurities and immune responses, compounded Epitalon was not allowed to be used. You can still get Epitalon in pill form.
Expert swap:
None right now
GHK-Cu
Copper peptides, or GHK-Cu, are made up of the tripeptide Glycyl-L-Histidyl-L-Lysine and copper ions. This peptide may help the body make more collagen, which is a protein that keeps skin flexible and firm. This has made it more famous in anti-aging skin care products . It is also thought that GHK-Cu is a strong antioxidant that may help wounds heal, lower inflammation, and speed up skin renewal.
What made it part of the FDA ban ?
That's why injectable GHK-Cu was banned: there was a high chance of immune reactions and impurities when it was being made. GHK-Cu can still be found in skin care items.
KPV
People are interested in KPV, a relatively new anti-inflammatory peptide, because it can speed up mending, stop infections, and get rid of chronic inflammation . One Reddit user, for example, says that KPV treatment helped them deal with their mast cell disease and histamine responses better.
What made it part of the FDA ban ?
So far, KPV has not been tested on people.
LL-37
There is a naturally occurring antimicrobial peptide called LL-37 that may help your body fight off dangerous bacteria, viruses, and fungi (27). This peptide has also been looked at as a possible anti-inflammatory drug, and studies suggest it might help treat face problems like rosacea .
What made it part of the FDA ban ?
Results from nonclinical studies show that LL-37 might make it harder for men to get pregnant. LL-37 might also be pro-tumorigenic, which means it might make tumors grow in some cells.
Melanotan II
Alpha-melanocyte-stimulating hormone (α-MSH) controls skin color, and melanotan II acts like it (28). A lot of people want to strengthen their tan by using this peptide.
What made it part of the FDA ban ?
Melanotan II was banned because it was linked to harmful effects such as melanoma skin cancers, posterior reversible encephalopathy syndrome (a disorder that causes seizures and headaches), sympathomimetic toxidrome (symptoms of poisoning), and priapism (dangerous, long-lasting erections).
Expert swap:
Scenesse, while primarily approved for the treatment of Porphyria, is occasionally used off-label for other conditions, such as cutaneous porphyria. However, its use can be cost-prohibitive for many patients.
MOTS-C
MOTS-C might speed up the metabolism and help muscles heal. Also, this peptide has shown potential in improving the function of mitochondria and the energy of cells .
What made it part of the FDA ban ?
Researchers have not yet shown that MOTS-C has the above effects. But the agency says that early results suggest that it could be used to treat metabolic diseases and conditions that come with getting older in the future.
Swaps by experts:
The respiration of cells depends on mitochondria. Mitochondrial failure is linked to a lot of different diseases because it affects many different parts of cells. By getting rid of harmful inflammatory substances like free radical oxygen species (ROS), SS-31 has been shown to fix mitochondrial failure.
SS-31 is one of a kind because it can get through the blood-brain barrier and collect a lot inside the inner membrane of the mitochondria (IMM). There is hope that SS-31 can help treat a number of neurodegenerative and brain diseases, including ALS, Alzheimer's, Friedreich ataxia, and glaucoma.
Researchers studying anti-aging are looking into SS-31 to see if it can fix mitochondrial failure and stop cells from dying too soon. The free radical theory of aging and the mitochondrial dysfunction theory of aging are linked, and the effects of SS-31 inside cells would help with both.
Thymosin Alpha 1
The man-made thymosin Alpha 1 is a form of the thymic peptide that has been shown to help the immune system (36). Some studies suggest that Thymosin Alpha 1 may help your body make more T-cells, which are cells that fight off infections and illnesses .
What made it part of the FDA ban?
It's possible that immune responses are linked to injectable Thymosin Alpha 1.
Expert swap:
None right now
Thymosin Beta 4
Thymosin Beta 4 is a naturally occurring protein that studies show might help fix and grow new tissues .. Initial study has shown that Thymosin Beta 4 can reduce inflammation and may be good for your heart health .
What made it part of the FDA ban?
The agency said that injectable Thymosin Beta 4 wasn't tested on people and there was a chance of immune response and peptide impurities. The ban didn't have any effect on the pill form of the peptide.
What made it part of the FDA ban ?
It's possible that immune responses are linked to injectable Thymosin Alpha 1.
Expert swap:
None right now
What if I'm already taking a peptide that isn't allowed?
1. Talk to your Physician about other options. The FDA hasn't banned all peptides, and many of the rules only apply to medicines that use compounded peptides. You might be able to keep going with treatment if you make a few changes to how it's given. It's only the liquid forms of peptides that are illegal, not the ones that are taken by mouth, like BPC-157 and Thymosin Beta 4. Talk to your doctor about a different peptide that you can take by mouth or get injected that will give you the same benefits.
2. Be careful with drugs from pharmacies that aren't controlled. The FDA has told compounding pharmacies they can't make certain peptides, but the government doesn't keep an eye on all pharmacies. These are called "unregulated pharmacies." It's possible that these pharmacies can still make peptides that aren't allowed, but if you do decide to go this way, be careful about the quality and safety. Heavy metals like mercury may be in the products that come from some pharmacies that aren't controlled. If you choose to get your peptide prescription from a pharmacy that isn't controlled, make sure it has good reviews and a recent certificate of authenticity (COA).
References
Forbes, et al (2023) Biochemistry, Peptide
Ng, et al (2000) Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone
Brinkman, et al (2023) Physiology, Growth Hormone
Garcia, et al (2019) Growth Hormone in Aging
Vukojevic, et al (2022) Pentadecapeptide BPC 157 and the central nervous system
Lee, et al (2021) Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain
Sikiric, et al (2016) Brain-gut Axis and Pentadecapeptide BPC 157: Theoretical and Practical Implications
Hsieh, et al (2017) Therapeutic potential of pro-angiogenic BPC157 is associated with VEGFR2 activation and up-regulation
Seiwerth, et al (2021) Stable Gastric Pentadecapeptide BPC 157 and Wound Healing
Liu, et al (2023) The effect of pentosan polysulfate sodium for improving dyslipidaemia and knee pain in people with knee osteoarthritis: A pilot study
ScienceDirect (2022) Larazotide
Alba, et al (2006) Once-daily administration of CJC-1295, a long-acting growth hormone-releasing hormone (GHRH) analog, normalizes growth in the GHRH knockout mouse
Teichman, et al (2006) Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults
Gautam, et al (2009) Neuronal M3 muscarinic acetylcholine receptors are essential for somatotroph proliferation and normal somatic growth
Walker, et al (2006) Sermorelin: A better approach to management of adult-onset growth hormone insufficiency?
Sun, et al (2021) AngIV-Analog Dihexa Rescues Cognitive Impairment and Recovers Memory in the APP/PS1 Mouse via the PI3K/AKT Signaling Pathway
Weiss, et al (2021) Stem cell, Granulocyte-Colony Stimulating Factor and/or Dihexa to promote limb function recovery in a rat sciatic nerve damage-repair model: Experimental animal studies
Gauthier, et al (2015) Cerebrolysin in mild-to-moderate Alzheimer’s disease: a meta-analysis of randomized controlled clinical trials
Zellinger, et al (2014) Impact of the Neural Cell Adhesion Molecule-Derived Peptide FGL on Seizure Progression and Cellular Alterations in the Mouse Kindling Model
Tukhovskaya, et al (2021) Delta Sleep-Inducing Peptide Recovers Motor Function in SD Rats after Focal Stroke
Hepsomali, et al (2020) Effects of Oral Gamma-Aminobutyric Acid (GABA) Administration on Stress and Sleep in Humans: A Systematic Review
Khavinson, et al (2020) AEDG Peptide (Epitalon) Stimulates Gene Expression and Protein Synthesis during Neurogenesis: Possible Epigenetic Mechanism
Shammas (2012) Telomeres, lifestyle, cancer, and aging
Pickart, et al (2018) Regenerative and Protective Actions of the GHK-Cu Peptide in the Light of the New Gene Data
Sinha, et al (2020) Beyond the androgen receptor: the role of growth hormone secretagogues in the modern management of body composition in hypogonadal males
Xiao, et al (2017) Orally Targeted Delivery of Tripeptide KPV via Hyaluronic Acid-Functionalized Nanoparticles Efficiently Alleviates Ulcerative Colitis
Reinholz, et al (2012) Cathelicidin LL-37: an antimicrobial peptide with a role in inflammatory skin disease
Gilhooley, et al (2021) Melanotan II User Experience: A Qualitative Study of Online Discussion Forums
Mohtashami, et al (2022) MOTS-c, the Most Recent Mitochondrial Derived Peptide in Human Aging and Age-Related Diseases
Liu, et al (2021) Structural basis of human ghrelin receptor signaling by ghrelin and the synthetic agonist ibutamoren
Volkova, et al (2016) Selank Administration Affects the Expression of Some Genes Involved in GABAergic Neurotransmission
Glazova, et al (2021) Semax, synthetic ACTH(4–10) analogue, attenuates behavioural and neurochemical alterations following early-life fluvoxamine exposure in white rats
Sudarkina, et al (2021) Brain Protein Expression Profile Confirms the Protective Effect of the ACTH(4–7)PGP Peptide (Semax) in a Rat Model of Cerebral Ischemia–Reperfusion
Djillani, et al (2017) Shortened Spadin Analogs Display Better TREK-1 Inhibition, In Vivo Stability and Antidepressant Activity
Xing, et al (2021) Progress on the Function and Application of Thymosin β4
Dominari, et al (2020) Thymosin alpha 1: A comprehensive review of the literature
Comments